The Small PLATEAU (PLATEAU-C) Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

Device Description

The Small PLATEAU (PLATEAU-C) Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either Titanium (Ti-6AI-4V ELI) or Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Small PLATEAU (PLATEAU-C) Spacer System components with components from any other system or manufacturer. The Small PLATEAU (PLATEAU-C) Spacer System components should never be reused under any circumstances.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "The Small PLATEAU® (PLATEAU-C) Spacer System," an intervertebral body fusion device. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness in the way one would describe for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976 (or has been reclassified). For devices cleared via 510(k), clinical studies demonstrating effectiveness in the same way as an AI/ML device are often not required if substantial equivalence can be shown through other means.

Therefore, most of your requested information (related to acceptance criteria for AI/ML performance, study details, expert ground truth, adjudication, MRMC studies, standalone performance, and training data) is not applicable to this type of regulatory submission.

Here is what can be extracted from the document based on your request, with an explanation of why other parts are not available:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document pertains to a physical intervertebral body fusion device, not an AI/ML system with quantifiable performance metrics like accuracy, sensitivity, or specificity. The "performance data" mentioned refers to the mechanical and design characteristics demonstrating substantial equivalence, not clinical efficacy or diagnostic performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is not an AI/ML device that was evaluated on a "test set" of data. The submission relies on engineering rationale and finite element analysis (FEA) to compare its mechanical properties to a predicate device, as well as similarity in design, materials, and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There was no "test set" requiring ground truth establishment by experts for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication was described for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No ground truth, in the context of diagnostic/AI performance, was used. The ground for substantial equivalence is based on regulatory standards for design, materials, and mechanical testing.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. No training set was used.

Summary of Device and Evidence Presented (as per the document):

Device Name: The Small PLATEAU® (PLATEAU-C) Spacer System
Device Type: Intervertebral Body Fusion Device
Regulatory Classification: Class II, Product Code ODP, 21 CFR 888.3080
Intended Use: Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1), to be used with autogenous bone graft and a supplemental internal spinal fixation system.
Materials: Titanium (Ti-6AI-4V ELI) or Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers.
Predicate Device: Small PLATEAU (PLATEAU-C) Spacer System (K111835) and Titan Spine Endoskeleton TC IBF (K100889)
Evidence for Substantial Equivalence:
- Comparison of design, materials, indications for use, and sizing to predicate devices.
- Performance Data: Finite element analysis and engineering rationale were presented to demonstrate substantial equivalency in terms of mechanical performance.

The FDA's review letter indicates that the device was found substantially equivalent based on these submissions, allowing it to be marketed. This clearance process does not involve clinical trials demonstrating improved patient outcomes or diagnostic performance in the way an AI/ML device would.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus-like symbol with three human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Life Spine, Inc. Mr. Randy Lewis General Manager 13951 S. Quality Drive Huntley, Illinois 60142

Re: K161127

Trade/Device Name: The Small PLATEAU® (PLATEAU-C) Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 23, 2016 Received: November 28, 2016

Dear Mr. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Vincent J. Devlin -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161127

Device Name

The Small PLATEAU® (PLATEAU-C) Spacer System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary The Small PLATEAU® (PLATEAU-C) Spacer System

Submitted By:	Life Spine Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	December 20th, 2016
Trade Name:	The Small PLATEAU® (PLATEAU-C) Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	ODP, 21 CFR 888.3080, Class II
Primary Predicate :	Small PLATEAU (PLATEAU-C) Spacer System (K111835)
Additional Predicate:	Titan Spine Endoskeleton TC IBF (K100889)

Device Description:

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Intended Use of the Device:

Technological Characteristics:

The Small PLATEAU (PLATEAU-C) Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Performance Data:

Finite element analysis and engineering rationale was presented to demonstrate the substantial equivalency of the Small PLATEAU (PLATEAU-C) Spacer System.

Substantial Equivalence:

The Small PLATEAU (PLATEAU-C) Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.